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Name
UMIN ID

Recruitment status Terminated
Unique ID issued by UMIN UMIN000027787
Receipt No. R000031809
Scientific Title Exploratory study to examine the effect of Ramelteon on end of life delirium
Date of disclosure of the study information 2017/06/23
Last modified on 2018/12/20

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Basic information
Public title Exploratory study to examine the effect of Ramelteon on end of life delirium
Acronym Exploratory study to examine the effect of Ramelteon on end of life delirium
Scientific Title Exploratory study to examine the effect of Ramelteon on end of life delirium
Scientific Title:Acronym Exploratory study to examine the effect of Ramelteon on end of life delirium
Region
Japan

Condition
Condition Advanced cancer
Classification by specialty
Not applicable
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate whether Ramelteon has a preventive effect on end of life delirium.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The incidence of delirium in a week
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Ramelteon 8mg/day
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. In palliative care unit
2. Possible to take medicine orally
3. Cancer associated pain is well controlled
4. Life expectancy is shorter than 1 months
5. Written informed consent
Key exclusion criteria 1. Having regular use of antipsychotics, antidepressants, antimanics and anticonvulsants.
2. Dementia
3. Serious complications such as liver failure, respiratory insufficiency, heart failure, or renal failure
4. Alcoholism or psychiatric patients
5. Already diagnosed delirium
6. Symptomatic intracranial lesions
Target sample size 22

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Inoue
Organization Tohoku University School of Medicine
Division name Department of Palliative Medicine
Zip code
Address 2-1, Seiryocho, Aobaku, Sendai
TEL 022-717-7366
Email akira.inoue.b2@tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yusuke Hiratsuka
Organization Tohoku University School of Medicine
Division name Department of Palliative Medicine
Zip code
Address 2-1, Seiryocho, Aobaku, Sendai
TEL 022-717-7366
Homepage URL
Email yusuke.hiratsuka.e6@tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

Funding Source
Organization Tohoku University School of Medicine, Department of Palliative Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 東北大学病院(宮城県)

Other administrative information
Date of disclosure of the study information
2017 Year 06 Month 23 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2017 Year 06 Month 22 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 06 Month 16 Day
Last modified on
2018 Year 12 Month 20 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031809

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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